ISPE_SFC pharma water sys
Transcript of ISPE_SFC pharma water sys
-
7/27/2019 ISPE_SFC pharma water sys
1/18
Pharmaceutical WaterSystems
Mason P. Waterbury
Nektar Therapeutics
28 June 05
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
2/18
Pharmaceutical Water Systems
Lets talk about:
What is High Purity Water?
How do we make High Purity Water?
How do we store and distribute High Purity Water?
Specific challenges / solutions
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
3/18
Pharmaceutical Water Systems
What is High Purity Water?
Purified Water (PW)
Sterile Purified Water (SPW)
Water for Injection (WFI)
Sterile Water for Injection (SWFI)
Water for Irrigation
Future Monographs (e.g., Water for Hemodialysis)
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
4/18
Pharmaceutical Water Systems
What is High Purity Water?
Purified Water (PW)
Sterile Purified Water (SPW)
Water for Injection (WFI)
Sterile Water for Injection (SWFI)
Water for Irrigation
Future Monographs
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
5/18
Pharmaceutical Water Systems
Purified Water
USP: . . .obtained by a suitable process Conductivity 1.3 S/cm @ 25 C Total Organic Carbon (TOC) 500 ppb Microbial 100 cfu/ml No endotoxin requirement
EP: . . .prepared by distillation, by ion exchange, byreverse osmosis or by any other suitable method
JP: . . .purified by distillation, ion-exchange treatment,ultrafiltration or combination of these methods
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
6/18
Pharmaceutical Water Systems
Purified Water Example System
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
7/18
Pharmaceutical Water Systems
Water for Injection (WFI)
USP: . . .distillation or a purification process that isequivalent of superior to distillation Conductivity 1.3 S/cm @ 25 C Total Organic Carbon (TOC) 500 ppb Microbial 10 cfu / 100 ml Endotoxin requirement < 0.25 EU/ml
EP: . . .distillation
JP: . . .distillation. . .or by the Reverse OsmosisUltrafiltration of Purified Water
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
8/18
Pharmaceutical Water Systems
Water for Injection (WFI) DistillationTechniques
Multi-Effect Still (MES) Uses Plant Steam to convert feedwater to pure steam
Separators allow impurities to drop out of the pure steam Pure steam from first effect used to convert feedwater topure steam in subsequent effects
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
9/18
Pharmaceutical Water Systems
Water for Injection (WFI) Distillation Techniques
Vapor Compression (VC) Uses plant steam to convert initial feedwater to vapor (pure steam) Pure steam is compressed, elevating temperature
Compressed vapor is used to evaporate new feedwater, giving uplatent heat and condensing as WFI
Higher electrical demand, but lower steam demand
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
10/18
Pharmaceutical Water Systems
High Purity Water Storage and Distribution Materials of Construction (Chemical and Heat
Compatibility) Stainless Steel (316 or 316L) Teflon, EPDM, Silicone, Viton (gaskets, diaphragms)
Fully Drainable (minimum slope 1/8 per foot, hygienicdesign of components)
Minimize Dead Legs (
-
7/27/2019 ISPE_SFC pharma water sys
11/18
Pharmaceutical Water Systems
Storage and Distribution Sanitization
Heat (Continuous or Periodic, >81 deg. C for >1 hour) Most popular nothing added to system If system continuously hot, all but eliminates concerns about
sanitization
Can be a utility hog Ozone
Gaining popularity Ozone destruction and monitoring very important Environmental concerns
Chemical Must ensure that cleaning chemicals are completely removed from
system
Rinsing post-sanitization time and cost intensive
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
12/18
Pharmaceutical Water Systems
Storage and Distribution Hot vs. Cold ?
Hot storage:
WFI produced through distillation is often generated hot, sowhy not store it hot?
Advantageous if there will be hot WFI distribution
Cold storage:
Periodic heat-up & cool-down of storage tank time- andenergy-intensive
Could expedite heat-up by dumping tank contents, but this is
wasteful Best solution will vary depending on specific
user requirements
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
13/18
Pharmaceutical Water Systems
Hot Storage, Hot and Ambient Distribution
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
14/18
Pharmaceutical Water Systems
Hot Storage, Hot and Ambient Distribution Cost-effective when there are many ambient
use points
Heat Sanitization of ambient loop by
displacement of AWFI or by heating ambientloop
Two loops mean increased installation labor
Only one heat exchanger means all ambientusers get water at same temperature, no localtemperature selection
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
15/18
Pharmaceutical Water Systems
Hot Storage, Hot Distribution with Use Point Coolers
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
16/18
Pharmaceutical Water Systems
Hot Storage, Hot Distribution with Use Point
Coolers Cost-effective when there are few ambient use points Main distribution loop is continuously hot, therefore
self-sanitizing
Can have locally adjustable use point temperaturesAmbient point-of-use piping must be sanitized byflushing or pulsing HWFI through heat exchanger todrain
Additional heat exchangers means increased capital
(and maintenance) cost Some feel POU cooler piping is a dead leg, prone tomicrobial growth
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
17/18
Pharmaceutical Water Systems
Hot Storage, Hot Distribution with Use PointCooler Sub-loops
http://www.ispe.org/ -
7/27/2019 ISPE_SFC pharma water sys
18/18
Pharmaceutical Water Systems
Hot Storage, Hot Distribution with Use Point CoolerSub-loops
Cost-effective when there are few ambient use points
Main distribution loop is continuously hot, therefore
self-sanitizing Heat exchanger piping kept hot when not in use
Can have locally adjustable use point temperatures
Dead leg question replaced by turbulent flow
question this becomes a balancing problemAdditional heat exchangers means increased capital
(and maintenance) cost
http://www.ispe.org/